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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) FRONTIER II; IMPLANTABLE PACEMAKER PULSE GENERATOR
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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) FRONTIER II; IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number 5586
Medical Device Problem Code Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/26/2018
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that when an asymptomatic patient presented in clinic during follow-up, device was found to be in backup vvi mode.It was noted that the patient had been lost to follow-up since post-implant device check.Device was explanted and replaced due to normal eri.Patient¿s condition was good post-procedure.
 
Additional Manufacturer Narrative
Field complaint of backup operation was confirmed and was due to normal battery depletion.Device was tested on bench and no anomalies were noted.
 
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Brand Name
FRONTIER II
Common Device Name
IMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key7787309
Report Number2938836-2018-09610
Device Sequence Number182515
Product Code NKE
UDI-Device Identifier05414734502948
UDI-Public05414734502948
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P030035
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2008
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/31/2009
Device Model Number5586
Device Lot Number0002134101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2018
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/26/2018
Supplement Date Received by Manufacturer10/04/2018
Initial Report FDA Received Date08/15/2018
Supplement Report FDA Received Date10/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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